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A Trial Evaluating Brelovitug (BJT-778) vs Bulevirtide for the Treatment of Chronic Hepatitis Delta Infection (AZURE-2)

View on ClinicalTrials.gov ↗

At a glance

What the study gets you: Access to the study treatment being tested
Type of study: Interventional (receives a drug or procedure)
Time in hospital: In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention: Brelovitug 300 mg (drug), Bulevirtide 2 mg and Brelovitug - 300 mg (drug)
How long the study runs: Study runs about 49 months (dates as stated)
About the drug or intervention: Brelovitug 300 mg — drug: Route of administration- Subcutaneous Injection · Bulevirtide 2 mg and Brelovitug - 300 mg — drug: Route of Administration- Subcutaneous Injection
Patient visit burden: Not specified by the sponsor

Type of study: Testing a treatment
Ages: 18 Years to 99 Years
Who: All
Number of participants: 172
Started: 2025-08-27
Last checked: 2026-10

Plain English Summary

What is this study?

• Testing a new treatment for chronic hepatitis d infection
• Phase3 - 172 participants
• This is a Phase 3, global, randomized, open-label, multicenter, trial evaluating brelovitug (BJT-778) vs bulevirtide for the treatment of chronic hepatitis delta infection (CHD)

Who can take part?

• Ages 18 Years to 99 Years
• Diagnosed with chronic hepatitis d infection

Where?

• Birmingham - Queen Elizabeth Hospital Birmingham
• London - Chelsea and Westminster Hospital NHS Foundation Trust
• Manchester - North Manchester General Hospital
• Cottingham - Hull University Teaching Hospitals
• +2 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

This is a Phase 3, global, randomized, open-label, multicenter, trial evaluating brelovitug (BJT-778) vs bulevirtide for the treatment of chronic hepatitis delta infection (CHD). The main goal of this study is to test the effectiveness of brelovitug compared to bulevirtide as a long-term treatment in patients with chronic HDV infection.

More detail

Study consists of 2 arms. Approximately 172 participants will be randomized 3:1 to one of the following treatment arms: Arm 1: Participants will receive brelovitug 300 mg subcutaneously once weekly for 96 weeks. Arm 2: Participants will receive bulevirtide 2 mg subcutaneously once daily for 48 weeks, followed by brelovitug 300 mg subcutaneously once weekly for the next 48 weeks.

Chronic Hepatitis D Infection

How this trial compares with your answers

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

Age: 18 Years - 99 Years
Who can join: All genders

What the study is looking for

✓Willing and able to provide written agreement to take part
✓Chronic HDV infection
✓HDV RNA \>500 IU/mL at Screening
✓liver enzymes \>ULN at Screening
✓Willing to take or already taking HBV neucleos(t)ide therapy.

Who cannot take part

✗Pregnant or nursing females
✗Unwilling to comply with contraception requirements during the study
✗Difficulty with blood collection and/or poor venous access for the purposes of phlebotomy
✗Clinical liver decompensation (i.e., ascites, encephalopathy variceal hemorrhage).
✗Solid organ or bone marrow transplantation

See the full criteria

Key Inclusion Criteria: 1. Willing and able to provide written informed consent 2. Chronic HDV infection 3. HDV RNA \>500 IU/mL at Screening 4. ALT \>ULN at Screening 5. Willing to take or already taking HBV neucleos(t)ide therapy. Key Exclusion Criteria: 1. Pregnant or nursing females 2. Unwilling to comply with contraception requirements during the study 3. Difficulty with blood collection and/or poor venous access for the purposes of phlebotomy 4. Clinical hepatic decompensation (i.e., ascites, encephalopathy variceal hemorrhage). 5. Solid organ or bone marrow transplantation 6. Presence of other liver disease(s) (non-HBV/HDV), such as nonalcoholic steatohepatitis (NASH), alcohol associated hepatitis, cholestatic liver disease, hepatocellular carcinoma. Note - Other protocol-defined Inclusion/Exclusion criteria apply.